 SAFC Biosciences can facilitate your successful movement through Phase I and Phase II with expertise related to cell banking, specifications, optimization and clinical manufacturing, as well as process lock down and risk management related to supply and sourcing.
Among our offer to you:
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Trouble-shooting and small-scale work: evaluation of pH shifts, bioreactor performance consistency, and metabolite profile issues. |
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Specifications: assistance with setting media and sera specifications |
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Evaluation of Phase II clinical manufacturing and possibilities related to disposable manufacturing processes. |
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Manufacture of Phase III clinical material: liquid media to dry powder media conversion, scaleability, feasibility and solubility. |
SAFC Biosciences has the knowledge, responsiveness, expertise and track record to move your clinical project through the development pipeline successfully. We have a 35-year background of clinical project development support and have helped companies move from discovery to successful commercialization; no other supplier can offer the same level of expertise at every stage of development. |
Phase I & II
Phase I trials are the first-stage of testing in human subjects and the main aim is to determine drug safety. Phase II trials are performed on larger groups and are aimed at identifying optimal dosages for future trials.
Tactical focuses during Phase I include safety, dose finding and immunogeneity, while the strategic focus is generally speed to market, developing a manufacturing process and decisions related to use of a contract manufacturing organization. Tactical focuses of Phase II include efficacy and process optimization, while the strategic focus is speed to market.
Phase I includes studies of the pharmacokinetics and pharmacodynamics of the protein in the human body. Typically a group of about 20 to 80 people will be selected. Trials are most frequently conducted in an inpatient clinic, where volunteer subjects can be observed by medical personnel.
There are two kinds of Phase I trials - SAD and MAD studies. SAD, or Single Ascending Dose, studies involved three or six patients who are given a small dose of the drug and who are then observed. If there are no adverse side effects, another group of patients will be given a higher does. This process continues until intolerable side effects begin; then the drug is said to have reached the Maximum tolerated dose (MTD).
MAD, or Multiple Ascending Dose, studies focus on better understanding the pharmacokinetics/pharmacodynamics of the drug. A group of patients receives a low drug dose, which is then escalated to a predetermined level. Blood and fluid samples are collected and analyzed to see how the body is processing the drug.
Phase II trials look at a drug's efficacy and side effects in a larger group, and are aimed at honing in on an optimal dose to be used in Phase III trials. Phase II is the point at which many drugs are identified that will not make it to the next phase. Sometimes Phase II is divided into Phase IIA and Phase IIB; the first is related to dosage with the second related to efficacy.
Some trials are a combination of Phase I and Phase II, with the single trial monitoring efficacy and toxicity.
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